System for Delivering an Anchor

ABSTRACT

A system for treating a prostate includes a cartridge, a handle configured to receive the cartridge, and an anchor assembly. The cartridge includes the anchor assembly and the handle includes an actuator and a spring mechanism loaded with mechanical energy. The cartridge and handle mate via pivoting and are aligned via alignment features.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of pending U.S.Provisional Application No. 61/819,507 filed May 3, 2013 entitled“Suture Anchoring Devices and Methods for Use,” which application isincorporated herein by reference in its entirety.

BACKGROUND OF THE DISCLOSURE

The present disclosure relates generally to medical devices and methods,and more particularly to systems and associated methods for manipulatingor retracting tissues and anatomical or other structures within the bodyof human or animal subjects for the purpose of treating diseases ordisorders.

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner end of the prostategland to squeeze the urethra. This pressure on the urethra increasesresistance to urine flow through the end of the urethra enclosed by theprostate. Thus the urinary bladder has to exert more pressure to forceurine through the increased resistance of the urethra. Chronicover-exertion causes the muscular walls of the urinary bladder toremodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

The most effective current methods of treating BPH carry a high risk ofadverse effects. These methods and devices either require general orspinal anesthesia or have potential adverse effects that dictate thatthe procedures be performed in a surgical operating room, followed by ahospital stay for the patient. The methods of treating BPH that carrylower risks of adverse effects are also associated with a lowerreduction in the symptom score. While several of these procedures can beconducted with local analgesia in an office setting, the patient doesnot experience immediate relief and in fact often experiences worsesymptoms for weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

There have been advances in developing minimally invasive devices andmethods for lifting and repositioning of tissues. However, furtheradvances are necessary to ensure an ability to access difficult to reachbody structure.

There remains a need for the development of new devices and methods thatcan be used to deploy multiple anchors from a single delivery device toimprove the user experience and minimizing patient discomfort. Anability to access anatomy with minimally invasive instruments whileviewing the interventional procedure is also desirable. Moreover,various structures ensuring an effective interventional procedure suchas implants having structural memory characteristics have been found tobe helpful in certain treatment approaches.

The present disclosure addresses these and other needs.

SUMMARY

Briefly and in general terms, the present disclosure is directed towardsan apparatus and method for deploying an anchor assembly within apatient's body to accomplish interventional treatments. A deliverydevice is provided to access the anatomy targeted for the interventionalprocedure. Some embodiments of the delivery device include mechanismsconfigured to deploy one or more anchor assemblies using a single handleassembly and multiple cartridge assemblies. Suitable embodiments of suchdelivery devices and anchor assemblies are described in co-pending U.S.patent application Ser. No. 13/833,299, filed Mar. 15, 2013, thedisclosure of which is incorporated by reference herein in its entirety.

The delivery apparatus of the present disclosure includes varioussubassemblies that are mobilized via an actuator or other manuallyaccessible structure. The operation of the subassemblies is coordinatedand synchronized to ensure accurate and precise implantation of ananchor assembly. In one embodiment, the delivery device is embodied in atissue approximation assembly that is configured to treat BPH.

In one particular aspect, the present invention is directed towards adelivery device that accomplishes the delivery of a first or distalanchor assembly component at a first location within a patient's bodyand the delivery of a second or proximal anchor assembly component at asecond location within the patient. Further, the delivery device caninclude mechanisms for efficient reloading of anchor assembles tominimize patient discomfort and enhance ease of use. The device can alsoaccomplish imparting tension during delivery to a connector to hold itwhile attaching the proximal anchor in situ. The procedure can be viewedemploying a scope inserted in the device. The scope can assume variousconfigurations and can be employed with complementary structureassisting in the viewing function. Also, the delivery device can besized and shaped to be compatible inside a sheath up to 24 F, preferablya 19 F or 20 F sheath or smaller.

The anchor assembly can be configured to accomplish approximating,retracting, lifting, compressing, supporting, remodeling, orrepositioning tissue within the body of a human or animal subject.Moreover, the apparatus configured to deploy the anchor assembly as wellas the anchor assembly itself are configured to complement and cooperatewith body anatomy.

In one aspect, a system for treating a prostate includes a cartridge, ahandle configured to receive the cartridge, and a delivery assembly. Thecartridge includes a distal anchor, a connector, and a proximal anchorand the handle includes an actuator, a spring mechanism loaded withmechanical energy. The delivery assembly includes a member that mateswith the cartridge to transfer the mechanical energy from the springmechanism to the cartridge and the actuator operates to reload themechanical energy.

In one aspect, a system for deploying an anchor assembly includes acartridge carrying the anchor assembly and a handle configured to couplewith the cartridge such that mechanical energy loaded in at least onespring mechanism within the handle is transferred to the cartridge todeploy the anchor assembly. The system includes an actuator configuredto initiate transfer of the mechanical energy and restore the majorityof the mechanical energy to the spring mechanisms.

In one aspect, a method for delivering a plurality of anchor assembliesincludes inserting a cartridge into a handle assembly. The handleassembly includes an actuator and a drive mechanism having a firstloaded configuration characterized by a total stored energy and anunloaded configuration. The cartridge includes at least one anchorassembly and a penetrating member. At least one anchor assembly and thepenetrating member are configured to advance from a distal portion ofthe cartridge. The method includes positioning the distal portion of thecartridge at an interventional site adjacent a prostate and operatingthe actuator to cycle the drive mechanism from the loaded configurationto the unloaded configuration to a second loaded configurationcharacterized by a total stored energy. Operating the actuatorsimultaneously delivers at least one anchor assembly to the prostate bytransferring load from the drive mechanism to the cartridge. The methodincludes removing the cartridge.

Various alternative methods of use are contemplated. The disclosedapparatus can be used to improve flow of a body fluid through a bodylumen, modify the size or shape of a body lumen or cavity, treatprostate enlargement, treat urinary incontinence, support or maintainpositioning of a tissue, close a tissue wound, organ or graft, perform acosmetic lifting or repositioning procedure, form anastomoticconnections, and/or treat various other disorders where a natural orpathologic tissue or organ is pressing on or interfering with anadjacent anatomical structure. Also, the invention has myriad otherpotential surgical, therapeutic, cosmetic or reconstructiveapplications, such as where a tissue, organ, graft or other materialrequires approximately, retracting, lifting, repositioning, compressionor support.

Other features and advantages of the present disclosure will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland.

FIG. 1B shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland treatedwith an embodiment of the device of the present invention.

FIG. 1C shows a side view of an embodiment of the retainer shown in FIG.1B.

FIGS. 1D through 1J show the various steps of a method of treating aprostate gland by the retainer shown in FIG. 1C.

FIG. 2 is a perspective view depicting one embodiment of an anchordelivery system.

FIG. 3 is a right side view depicting the anchor delivery system of FIG.2.

FIG. 4 is a perspective view in partial cross-section depicting partialadvancement of a needle assembly.

FIG. 5 is a perspective view of an anchor delivery system including acartridge and a handle.

FIGS. 6 through 8 are perspective views of an anchor delivery systemincluding a cartridge and a handle where the cartridge is beingpositioned within the handle.

FIG. 9 is a perspective view of an anchor delivery system including acartridge and a handle showing alignment members on the cartridge andhandle.

FIG. 10 is a cross-sectional view of the alignment members on thecartridge and handle of an anchor delivery system.

FIGS. 11 and 12 are views of a cartridge of an anchor delivery system.

FIG. 13 is a view of the distal portions of a scope and a cartridgeshaft.

FIG. 14 is a cross-section view of portions of a scope and a cartridgeshaft.

FIG. 15 illustrates a cartridge shaft and handle shaft entering asheath.

FIG. 16 illustrates and embodiment of a cartridge shaft.

FIG. 17 depicts a kit including a handle assembly and four cartridgeassemblies.

FIGS. 18A through 18D depict various designs for cartridge handles.

FIGS. 19A through 19C depict an actuation sequence for a handle.

FIGS. 20A through 20D depict different shapes and configurations for ahandle assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the figures, which are provided by way of example and notlimitation, the present disclosure is directed to a device configured todeliver multiple anchor assemblies within a patient's body for treatmentpurposes. The disclosed apparatus can be employed for various medicalpurposes including but not limited to retracting, lifting, compressing,approximating, supporting, remodeling, or repositioning tissues, organs,anatomical structures, grafts or other material found within a patient'sbody. Such tissue manipulation is intended to facilitate the treatmentof diseases or disorders such as the displacement, compression and/orretraction of the body tissue.

In an aspect of the present disclosure, the delivery device includes ahandle assembly supporting an elongate member. The elongate memberdefines a low profile that is suited to navigate body anatomy to reachan interventional site. Substructure is provided to maintain alongitudinal profile of the elongate member so that the interventionalprocedure can progress as intended.

In another aspect, one portion of an anchor assembly or implant ispositioned and implanted against a first section of anatomy. A secondportion of the anchor assembly or implant is then positioned andimplanted adjacent to a second section of anatomy for the purpose ofretracting, lifting, compressing, approximating, supporting, remodeling,or repositioning the second section of anatomy with respect to the firstsection of anatomy as well as for the purpose of retracting, lifting,compressing, approximating, supporting, remodeling, or repositioning thefirst section of anatomy with respect to the second section of anatomy.It is also to be recognized that both a first and second portion of theanchor assembly can be configured to accomplish the desired retracting,lifting, compressing, approximating, supporting, remodeling, orrepositioning of anatomy due to tension supplied during delivery via aconnector assembly affixed to the first and second portions of theanchor assembly or implant. The delivery device can include an endoscopeproviding the ability to view the interventional procedure.

FIG. 1A shows a coronal section (i.e., a section cut approximately inthe plane of the coronal suture or parallel to it) through the lowerabdomen of a male human suffering from BPH showing a hypertrophiedprostate gland. As depicted in FIG. 1A, the urinary bladder UB is ahollow muscular organ that temporarily stores urine. It is situatedbehind the pubic bone PB. The lower region of the urinary bladder has anarrow muscular opening called the bladder neck, which opens into asoft, flexible, tubular organ called the urethra UT. The muscles aroundthe bladder neck are called the internal urethral sphincter. Theinternal urethral sphincter is normally contracted to prevent urineleakage. The urinary bladder gradually fills with urine until fullcapacity is reached, at which point the sphincters relax. This causesthe bladder neck to open, thereby releasing the urine stored in theurinary bladder into the urethra. The urethra conducts urine from theurinary bladder to the exterior of the body. The urethra begins at thebladder neck and terminates at the end of the penis. The prostate glandPG is located around the urethra at the union of the urethra and theurinary bladder. In FIG. 1A, the prostate gland is hypertrophied(enlarged). This causes the prostate gland to press on a region of theurethra. This in turn creates an undesired obstruction to the flow ofurine through the urethra.

FIG. 1B shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland treatedwith an embodiment of the device of the present invention. It has beendiscovered that the enlarged prostate gland is compressible and can beretracted so as to relieve the pressure from the urethra. In accordancewith one embodiment of the present invention, a retaining device can beplaced through the prostate gland in order to relieve the pressure onthe urethra. In FIG. 1B, a retainer 10 is implanted in the prostategland. Retainer 10 comprises a distal anchor 12 and a proximal anchor14. Distal anchor 12 and a proximal anchor 14 are connected by aconnector 16. The radial distance from the urethra to distal anchor 12is greater than the radial distance from the urethra to proximal anchor14. The distance or tension between the anchors is sufficient tocompress, displace or change the orientation of an anatomical regionbetween distal anchor 12 and proximal anchor 14. The connector 16 can beinelastic so as to maintain a constant force or distance between theproximal and distal anchors or be elastic so as to attempt to draw theproximal and distal anchors closer together. In the embodiment shown inFIG. 1B, distal anchor 12 is located on the outer surface of the capsuleof prostate gland CP and acts as a capsular anchor. Alternatively,distal anchor 12 may be embedded inside the tissue of prostate gland PGor in the surrounding structures around the prostate such as periosteumof the pelvic bones, within the bones themselves, pelvic fascia, coopersligament, muscles traversing the pelvis or bladder wall. Also, in theembodiment shown in FIG. 1B, proximal anchor 14 is located on the innerwall of urethra UT and acts as a urethral anchor. Alternatively,proximal anchor 14 may be embedded inside the tissue of prostate glandPG or surrounding structures as outlined above. Distal anchor 12 andproximal anchor 14 are implanted in the anatomy such that a desireddistance or tension is created in connector 16. This causes distalanchor 12 and proximal anchor 14 to retract or compress a region ofprostate gland PG to relieve the obstruction shown in FIG. 1A. In FIG.1B, two retainers 10 are implanted in prostate gland PG. Each retainer10 is implanted in a lateral lobe (side lobe) of prostate gland PG. Thevarious methods and devices disclosed herein may be used to treat asingle lobe or multiple lobes of the prostate gland or other anatomicalstructures. Similarly, two or more devices disclosed herein may be usedto treat a single anatomical structure. For example, a lateral lobe ofprostate gland PG may be treated using two retainers 10. One or moreretainers may be deployed at particular angles to the axis of theurethra to target one or more lateral lobes and/or middle lobe of theprostate gland. In one embodiment, retainer 10 is deployed between the 1o'clock and 3 o'clock position relative to the axis of the urethra totarget the left lateral lobe of the prostate gland. In anotherembodiment, retainer 10 is deployed between the 9 o'clock and 11 o'clockposition relative to the axis of the urethra to target the right laterallobe of the prostate gland. In another embodiment, retainer 10 isdeployed between the 4 o'clock and 8 o'clock position relative to theaxis of the urethra to target the middle lobe of the prostate gland.

FIG. 1C shows a side view of one embodiment of the retainer shown inFIG. 1B. FIG. 1C shows retainer 10 comprising distal anchor 12 andproximal anchor 14. Distal anchor 12 and proximal anchor 14 areconnected by connector 16. In the embodiment shown in FIG. 1C, distalanchor 12 comprises a tube 18 having a lumen. Tube 18 can be made ofsuitable elastic or non-elastic materials including, but not limited tometals, polymers, etc. Typical examples of such materials include, butare not limited to stainless steel 304, stainless steel 316,nickel-Titanium alloys, titanium, Pebax, Polyimide, braided Polyimide,Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE,shape memory polymers, such as polyesterurethane, polyetherurethane,polyetherpolyesters, polyetherpolyamines or combinations of oligoe-caprolactore diol and oligo p-dioxanone diol polymers, etc. Connector16 is attached to tube 18. In one embodiment, connector 16 is a USP size0 polypropylene monofilament suture. In the embodiment shown in FIG. 1C,a distal region of connector 16 is located in the lumen of tube 18 suchthat the distal tip of connector 16 emerges out of one end of the lumenof tube 18. The distal tip of connector 16 is enlarged, such that thediameter of the enlarged distal tip of connector 16 is greater than theinner diameter of tube 18. In one embodiment, the diameter of connector16 is 0.014 inches and the diameter of the enlarged distal tip ofconnector 16 is 0.025 inches. In one embodiment, the enlarged distal tipof connector 16 is created by controlled melting of the distal tip ofconnector 16. This attaches connector 16 to tube 18. Tube 18 maycomprise one or more additional attachment mechanisms to attach a distalregion of connector 16 to tube 18. In one embodiment, the distal regionof connector 16 is attached to tube 18 by a suitable biocompatibleadhesive. In the embodiment shown in FIG. 1C, the distal region ofconnector 16 is attached to tube 18 by one or more inwardly openingflaps 20 that are cut in the material of tube 18. Flaps 20 gripconnector 16 and thus prevent the relative motion of connector 16 andtube 18. The angle between one of flaps 20 and connector 16 may rangefrom 1 degree to 90 degrees. Tube 18 further comprises a longitudinalslot 22. Longitudinal slot 22 extends from one end to roughly the midsection of tube 18. Connector 16 emerges out of this longitudinal slot22. Thus, when connector 16 is pulled in the proximal direction, distalanchor 12 assumes a T-shape that helps to anchor distal anchor 12 to ananatomical structure. Distal anchor 12 may comprise a sharp edge to helppenetrate distal anchor 12 through the anatomy. In a preferredembodiment, distal anchor 12 is constructed by laser cutting andelectropolishing a nickel-titanium alloy (e.g., nitinol) tube made of50.8% nickel-49.2% titanium. In the preferred embodiment, the outerdiameter of tube 18 is 0.026 inches, the inner diameter of tube 18 is0.015 inches, the length of tube 18 is 0.315 inches and the length oflongitudinal slot 22 is 0.170 inches.

In the embodiment shown in FIG. 1C, proximal anchor 14 comprises a tube24 comprising a lumen. Tube 24 can be made of suitable elastic ornon-elastic materials including, but not limited to metals, polymers,etc. Typical examples of such materials include, but are not limited tostainless steel 304, stainless steel 316, nickel-Titanium alloys,titanium, Pebax, Polyimide, braided Polyimide, Polyurethane, Nylon, PVC,Hytrel, HDPE, PEEK, PTFE, PFA, FEP, ePTFE, such as polyesterurethane,polyetherurethane, polyetherpolyesters, polyetherpolyamines orcombinations of oligo e-caprolactone diol and oligo p-dioxanone diolpolymers, etc. An outwardly opening flap 26 is cut through the materialof tube 24. Flap 26 is folded on the outer surface of tube 18 as shownin FIG. 1C. This creates an opening to the lumen of tube 24 that islined by the atraumatic edge of the folded flap 26. Connector 16 enterstube 24 through this opening to the lumen of tube 24. Proximal anchor 14further comprises an attachment mechanism to attach connector 16 to tube24. Connector 16 can be made of suitable elastic or non-elasticmaterials including, but not limited to metals, polymers, etc. Otherproximal anchor and distal anchor concepts are within the scope of theinvention, such as v-shaped proximal anchors that are press fit onto aconnector. Typical examples of such materials include, but are notlimited to stainless steel 304, stainless steel 316, nickel-Titaniumalloys, suture materials, titanium, silicone, nylon, polyamide,polyglycolic acid, polypropylene, Pebax, PTFE, ePTFE, silk, gut, or anyother braided or mono-filament material. In a preferred embodiment, tube24 has a length of 0.236 inches and an outer diameter of 0.027 inchesand an inner diameter of 0.020 inches. The length of opening to thelumen of tube 24 is approximately 0.055 inches. In the preferredembodiment, the attachment mechanism comprises a lock pin thatfrictionally attaches connector 16 to tube 24. The lock pin and tube 24are made of stainless steel 316L. In the preferred embodiment, tube 24is laser cut or stamped and then electropolished. Lock pin isconstructed using EDM (electrical discharge machining) and thenpassivated.

FIGS. 1D through 1J show the various steps of a method of treating aprostate gland by the retainer shown in FIG. 1C. Similar methods may bealso used to deploy retainer or compression devices in other anatomicalstructures. In the step shown in FIG. 1D, a sheath 28 such as a standardresectoscope sheath is introduced into the urethra (trans-urethrally).Sheath 28 is advanced through urethra UT such that the distal end ofsheath 28 is positioned near a region of urethra UT that is obstructedby a hypertrophied prostate gland PG. Distal anchor delivery device 30is introduced through sheath 28. Distal anchor delivery device 30 can beplaced in the sheath 28 after the distal end of sheath 28 is positionednear the region of the urethra UT that is obstructed or the distalanchor delivery device 30 can be pre-loaded in the sheath 28 beforepositioning of the sheath 28. Distal anchor delivery device 30 isadvanced through sheath 28 such that the distal end of distal anchordelivery device 30 emerges out of the distal end of sheath 28. Distalanchor delivery device 30 is oriented such that a working channelopening of distal anchor delivery device 30 points towards a laterallobe of prostate gland PG.

In the step shown in FIG. 1E, a needle 32 is introduced through distalanchor delivery device 30. Needle 32 can be placed in distal anchordelivery device after the distal anchor delivery device 30 is advancedthrough sheath 28 or the needle 32 can be pre-loaded in the distalanchor delivery device 30. In one embodiment, needle 32 is a 20 gaugeneedle. Needle 32 is advanced through distal anchor delivery device 30such that it emerges through the working channel opening. Needle 32 isfurther advanced such that it penetrates through the tissue of prostategland PG and the distal end of needle 32 emerges out of the capsule ofprostate gland CP.

In the step shown in FIG. 1F, distal anchor 12 connected to connector 16is advanced through needle 32. Distal anchor 12 can be pre-loaded inneedle 32 or can be loaded in needle 32 after needle 32 has beenadvanced through distal anchor delivery device 30. Distal anchor 12 isadvanced through needle 32 such that it emerges out of the distal end ofneedle 32. In alternate embodiments, the distal anchor can be held inplace by a pusher or connector while the needle is retracted, thusexposing the distal anchor.

In the step shown in FIG. 1G, needle 32 is removed from distal anchordelivery device 30 by pulling needle 32 in the proximal direction.

In the step shown in FIG. 1H, distal anchor delivery device 30 isremoved from sheath 28 by pulling distal anchor delivery device 30 inthe proximal direction. Also, connector 16 is pulled to orient distalanchor 12 perpendicularly to connector 16.

In the step shown in FIG. 1I, connector 16 is passed through proximalanchor 14 located on a proximal anchor delivery device 34. Proximalanchor delivery device 34 is advanced through sheath 28 such that thedistal end of proximal anchor delivery device 34 emerges out of thedistal end of sheath 28. A desired tension is introduced in connector 16such that distal anchor 12 is pulled by connector 16 with a desiredforce. Alternatively, the proximal anchor can be visualized through anendoscope or under fluoroscopy and advanced along the connector untilthe desired refraction of the tissue is achieved. In other embodiments,the proximal anchor is a v-shaped or clothespin-shaped piece that isforced, in some cases at high speed, onto the connector to fixedlyengage the connector.

In the step shown in FIG. 1J, connector 16 is attached to proximalanchor 14. Proximal anchor 14 is also released from proximal anchordelivery device 34, thus deploying proximal anchor 14 in the anatomy.Proximal anchor delivery device 34 and sheath 28 are removed form theanatomy. Retainer 10 comprising distal anchor 12, proximal anchor 14 andconnector 16 is used to retract, lift, support, reposition or compress aregion of prostate gland PG located between distal anchor 12 andproximal anchor 14. This method may be used to retract, lift, support,reposition or compress multiple regions or lobes of the prostate glandPG. In the method shown in FIGS. 1D through 1J, distal anchor 12 isdeployed on the outer surface of the capsule of prostate gland CP. Thus,distal anchor 12 acts as a capsular anchor. Alternatively, distal anchor12 may be deployed inside the tissue of prostate gland PG or beyond theprostate as outlined previously. Similarly, in the method shown in FIGS.1D through 1J, proximal anchor 14 is deployed on the inner wall ofurethra UT and acts as a urethral anchor. Alternatively, proximal anchor14 may be deployed inside the tissue of prostate gland PG.

The tissue approximation anchor shown in FIG. 1C is designed to beuseable in a physician's clinical office environment (in contrast torequiring a hospital environment) with a delivery tool. The deliverytool is used through a 19 F or 20 F sheath in one preferred embodiment.Additionally, the material selection and construction of the tissueapproximation anchor still allows for a subsequent TURP procedure to beperformed, if necessary, on the prostate. In this suture-based, tissueapproximation technique, a needle delivery mechanism is used to implantan anchor assembly.

Referring now to FIGS. 2-4, there is shown one embodiment of a deliverydevice 100. This device is configured to include structure that iscapable of both gaining access to an interventional site as well asassembling and implanting one or more anchor assemblies or implantswithin a patient's body. The delivery device 100 can be configured toassemble and implant a single anchor assembly or implant a single bodiedanchor or multiple anchors or anchor assemblies. The device is furthercontemplated to be compatible for use with a 19 F or 20 F sheath. Thedevice additionally includes structure configured to receive aconventional remote viewing device (e.g., an endoscope) so that thesteps being performed at the interventional site can be observed.

Prior to use of the present device 100, a patient typically undergoes afive day regimen of antibiotics. A local anesthesia can be employed forthe interventional procedure. A combination of an oral analgesic with asedative or hypnotic component can be ingested by the patient. Moreover,topical anesthesia such as lidocaine liquids or gel can be applied tothe bladder and urethra.

The anchor delivery device 100 includes a handle assembly 102 connectedto elongate member 104. Elongate member 104 can house componentsemployed to construct an anchor assembly and is sized to fit into a 19 For 20 F cystosopic sheath for patient tolerance during a procedure inwhich the patient is awake rather than under general anesthesia. Theassembly is intended to include structure to maintain its positioningwithin anatomy.

The anchor delivery device 100 further includes a number ofsubassemblies. A handle case assembly 106 including mating handle partsthat form part of the handle assembly 102. The handle assembly 102 issized and shaped to fit comfortably within an operator's hand and can beformed from conventional materials. Windows can be formed in the handlecase assembly 106 to provide access to internal mechanisms of the deviceso that a manual override is available to the operator in the event theinterventional procedure needs to be abandoned.

In one embodiment, the delivery device 100 is equipped with variousactivatable members that facilitate assembly and delivery of an anchorassembly at an interventional site. A needle actuator 108 is providedand as described in detail below, effectuates the advancement of aneedle assembly to an interventional site. In one approach, the needleassembly moves through a curved trajectory and exits the needle housingin alignment with a handle element, and in particular embodiments, inalignment with the grip. In various other embodiments, the needlehousing is oriented such that the needles exits the housing at eitherthe two o'clock or ten o'clock positions relative to a handle grip thatis vertical. A needle refraction lever assembly 110 is also provided andwhen actuated causes the needle assembly to be withdrawn and expose theanchor assembly.

In one particular, non-limiting use in treating a prostate, the elongatemember 104 of a delivery device is placed within a urethra (UT) leadingto a urinary bladder (UB) of a patient. In one approach, the deliverydevice can be placed within an introducer sheath (not shown) previouslypositioned in the urethra or alternatively, the delivery device can beinserted directly within the urethra. When employing an introducersheath, the sheath can be attached to a sheath mount assembly (describedbelow). The patient is positioned in lithotomy. The elongate member 104is advanced within the patient until a leading end thereof reaches aprostate gland (PG). In a specific approach, the side(s) (or lobe(s)) ofthe prostate to be treated is chosen while the device extends throughthe bladder and the device is turned accordingly. The inside of theprostate gland, including the adenoma, is spongy and compressible andthe outer surface, including the capsule, of the prostate gland is firm.By the physician viewing with an endoscope, he/she can depress theurethra into the prostate gland compressing the adenoma and creating thedesired opening through the urethra. To accomplish this, the physicianrotates the tool. The physician then pivots the tool laterally about thepubic symphysis PS relative to the patient's midline.

The delivery device is at this stage configured in a ready state. Theneedle actuator 108 and the needle retracting lever 110 are in aninactivated position.

Upon depression of the needle actuator 108, the needle 230 (See FIG. 4)is advanced from within the elongate member 104. The needle can beconfigured so that it curves back toward the handle as it is ejected. Inuse in a prostate intervention, the needle is advanced through andbeyond a prostate gland (PG). Spring deployment helps to ensure theneedle passes swiftly through the tough outer capsule of the prostatewithout “tenting” the capsule or failing to pierce the capsule. In oneapproach, the needle is made from Nitinol tubing and can be coated withParylene N. Such a coating helps compensate for frictional orenvironmental losses (such as wetness) that may degrade effectiveness ofneedle penetration.

Certain anchor delivery devices include springs as part of themechanisms that drive a needle or penetrating member, deploy an anchor,cut a connector, or perform other functions related to device delivery.The devices may include springs that are preloaded with potential energywhen the user removes the device from packaging. Preloaded springs canbe susceptible to degradation over time when stored in a loaded state,whether that state is tension or compression. Spring degradation mayaffect a device's shelf life. Also, spring degradation can affect theconsistency of the device as the spring force can change over time.Further, loaded components may creep due to constant stress.

FIG. 5 illustrates one embodiment of an anchor delivery system 200including a handle assembly 300 and a cartridge assembly 400. Cartridgeassembly 400 is sized, shaped, and configured to couple to handleassembly 300. Cartridge assembly 400 contains one or more anchors, suchas retainer 10 depicted in FIG. 1C. Cartridge assembly 400 includesfeatures that mate with features on the handle assembly 300 to transmitmechanical forces from the handle assembly 300 to the cartridge assembly400. For example, squeezing a lever (not pictured) on handle grip 310can actuate mechanical forces, such as spring loaded mechanical forces,that are transmitted to the cartridge assembly 400 for deploying ananchor, such as retainer 10.

Handle assembly 300 includes handle shaft 320, which has a lumenconfigured to allow passage of an endoscope through it. Such anendoscope (not pictured) can extend proximally through the handleassembly 300 and out scope lock 322. Handle assembly 300 includescartridge chamber 350, which is configured to accept the body portion ofcartridge assembly 400. Within cartridge chamber 350 are features thatmate with the features of cartridge assembly 400 to transmit mechanicalforces.

At the proximal end of the interior of cartridge chamber 350 is guide360, which protrudes distally from the proximal wall of the cartridgechamber 350. A proximal portion of cartridge assembly 400 includesreceiver 460, which interacts with guide 360 when the cartridge assembly400 is placed within cartridge chamber 350. Cartridge assembly 400 canbe held be cartridge grip 410 when being manipulated to be placed withincartridge chamber 350.

FIG. 6 depicts cartridge assembly 400 being tilted with the endincluding receiver 460 positioned toward cartridge chamber 350. At sucha tilted angle, receiver 460 can interact with guide 360. FIG. 7 depictsthe proximal portion of cartridge assembly 400 within cartridge chamber350 and receiver 460 engaged with guide 360. In certain embodiments,receiver 460 and guide 360 interact to allow receiver 460 to pivot aboutguide 360. When cartridge assembly 400 is substantially within cartridgechamber 350, such as depicted in FIG. 8, guide 360 interacts withreceiver 460 to prevent cartridge assembly 400 from laterally escapingfrom cartridge chamber 350.

The retainer and guide are depicted as interacting in a rotationalfashion such that the retainer allow the cartridge to pivot about theguide and become securely placed within the cartridge chamber. However,other configurations and interactions between a retainer and guide arewithin the scope of the invention. For example, in certain embodimentsthe guide is a hinge-like feature that mates with the retainer and themated retainer/guide assembly rotates together to align the cartridgeassembly within the cartridge chamber. In another embodiment, thecartridge can be guided into the chamber with other types of motions,such as a linear motion.

FIG. 9 depicts a view of anchor delivery system 200 in which cartridgeassembly 400 has been partially placed within the cartridge chamber ofhandle assembly 300. FIG. 9 depicts the relationship of cartridgeassembly 400 and handle assembly 300 as cartridge assembly is beingpivoted into place to assume the configuration of the system depicted inFIG. 8. In this view, the interaction of handle alignment member 330 andcartridge alignment member 430. As depicted in FIG. 10, which is across-sectional view, cartridge alignment member 430 mates with handlealignment member 330. In this embodiment, cartridge alignment member 430has a wedge shape that fits within the wedge recess of handle alignmentmember 330. In some embodiments, the handle alignment member 330 has awedge shape that fits within the wedge recess of cartridge alignmentmember 430. The interaction of the wedge shape and wedge recess providesan aligned orientation of the cartridge and handle.

In certain embodiments, the proximal portion of sheath 28 fits over theunion of cartridge alignment member 430 and handle alignment member 330.Each of these members can have a distal taper. For example, FIG. 11depicts tapered section 431 of cartridge alignment member 430. Suchtapered sections on one or both of the alignment members enables thesheath to slide over the union of the alignment members andsimultaneously cinch together the wedge and wedge recess of the members.These embodiments take advantage of the presence of the sheath in theurological procedure to secure, or improve the security of, thecartridge and the handle. Further, the sheath can include a lockingdevice. The locking device can interact with the alignment members or itcan further secure the alignment members that have been slid within thesheath when the locking device is locked. An alternative embodiment doesnot utilize a sheath and has a slidably engaging cinching member on thecartridge shaft 450 or handle shaft 320.

FIGS. 11 and 12 depict views of cartridge assembly 400, which includescartridge shaft 450 extending from a distal portion of the cartridgeassembly 400. Cartridge shaft 450 is configured to interact with anendoscope (not pictured) that is coupled to the handle assembly. Theproximal portion of cartridge shaft 450 aligns with handle shaft 320(depicted in FIGS. 5 through 7, for example) via the handle andcartridge alignment members disclosed herein (or their equivalents). Thedistal portion of cartridge shaft 450 aligns with the distal portion ofthe endscope. The distal portion of each can interact via a pressfitting, a friction fit, or other equivalent mechanism.

In certain embodiments, the cartridge shaft 450 is slightly biasedtoward the position of the endscope such that the distal portion of thecartridge shaft 450 is deflected by a few degrees in the direction ofthe endoscope. FIG. 13 depicts a distal portion of a scope 50, which issubstantially straight, and a distal portion of cartridge shaft 450,which is biased towards the scope. When the distal portions are placedadjacent by pivoting the cartridge assembly in the handle assembly asdescribed herein (or via a similar method of placing the cartridgeassembly within the handle assembly), the biased portion of the shaftdeflects to substantially align with the longitudinal axis of the scope.Alternatively, the cartridge shaft 450 could engage onto the handleshaft 320 through a close fit or snap fit.

The proximal portion of the cartridge shaft can be aligned with thescope via the alignment members and the distal portion of the cartridgeshaft can be aligned with the scope via the biasing of that distalportion. FIG. 14 depicts a cross-sectional view of the cartridge shaft450 and the scope according to one embodiment. The middle portion of thecross-section includes a scope lumen 455. One either side of the scopelumen 455 are upper lumen 452 and lower lumen 458. In this embodiment,when the scope 50 is aligned and fit at least partially within the scopelumen 455, the scope 50 forms an additional wall for both upper lumen452 and lower lumen 458. The scope lumen 455 is sized and configured toprovide a relatively close fit with the scope. Thus, embodiments of theinvention provide mechanisms for aligning the proximal, distal, andmiddle sections of the cartridge shaft with a scope.

While lumens 452 and 458 are described as upper and lower lumens, in usethese lumens are not necessarily in an upper and lower orientation. Forexample, in embodiments where the physician uses the delivery devicecoupled with the endoscope to depress the urethra into the prostategland compressing the adenoma and creating the desired opening throughthe urethra, lumens 452 or 458 are in contact with the prostate gland.The outer surface of these lumens is the surface of the device that isapplying pressure to the prostate gland. The delivery device and theendoscope are therefore able to move together without the risk of thescope exiting the open side of cartridge shaft 452 because the directionof pressure is generally orthogonal to that opening.

The upper and lower lumens of the cartridge shaft are used to house anddeploy parts of the anchors delivered by the anchor delivery system. Theanchor components can be housed in a distal portion of the lumens of thecartridge shaft. A substantial portion of the length of these lumens maycontain pusher or puller mechanisms to transmit mechanical forces fromthe handle to the distal portion of the cartridge shaft to assemble theanchor as described herein.

FIGS. 15 and 16 depict features 459 configured to engage the sheath 60.These spring features can be included on the cartridge shaft 450 or thehandle shaft 320 to bias one shaft towards the other as the anchordelivery system is advanced into the sheath. Other features, such asbumps, protrusions, ridges, and the like, that enhance the alignment ofthe cartridge shaft and handle shaft can be included on each.

FIG. 17 depicts a kit including a handle assembly 300 and four cartridgeassemblies 400. FIGS. 18A through 18D depict various designs for acartridge grip 310 to facilitate proper placement of a cartridge withinthe handle.

FIGS. 19A through 19C depict an actuation sequence for a handle 300. InFIG. 19A, at position A, the lever 315 is fully extended and the deviceis ready for operation. When pulled to position B, the needle deploysfrom the distal portion of the device. At position C, the needleretracts back into the device. In FIG. 19B, the lever 315 has returnedto its fully extended position A and is ready for a second squeezesequence, which further retracts the needle back into the device untilposition C where the connector attached to the distal anchor istensioned. In FIG. 19C, the lever 315 has returned to its fully extendedposition A and is ready for a third squeeze sequence. At position B, thesecond (or proximal) anchor is attached to the connector, which is cutproximal to this second connection. At position C, energy has been fullyrestored to the relevant springs and the lever 315 is free to return toposition A to begin a new delivery sequence with a new cartridge.

FIGS. 20A through 20D depict various shapes and configurations of ahandle 300. The handle 300 can have one lever 315, such as depicted inFIGS. 20B, 20C, and 20D, or the handle can have more than one lever,such as levers 315 a and 315 b depicted in FIG. 20A. FIGS. 20B, 20C, and20D depict various embodiments of a handle ridge 302 and handle recess301. The handle ridge 302 and handle recess 301 cooperate to provide anergonomic interface to the user's hands with the handle 300. In someinstanced, the procedure is best accomplished with subtle movements ofthe handle and the handle ridge 302 and handle recess 301 can providesecure and comfortable interaction between the handle 300 and the user.

The method of use of the anchor delivery system can incorporate the useof a cystoscope, endoscope, or similar visualization device. In someembodiments, the proximal handle includes a scope lock with no movingparts for locking a cystoscope to the handle prior to performing thetreatments disclosed herein. The lack of moving parts reduces the costand increases the reliability and ease of use.

Embodiments described herein provide several advantages, including, butnot limited to, the ability to efficiently deliver multiple anchorassemblies while reducing patient discomfort and increasing ease-of-use.Certain embodiments provide mechanisms for, with a single lever orequivalent actuator, delivering an anchor assembly and recharging thestored energy in the delivery device such that the device is ready ornear ready to deliver another anchor assembly by simply replacing acartridge in the delivery system.

Accordingly, the present invention contemplates both pushing directly onanchor portions of an anchor assembly as well as pushing directly uponthe connector of the anchor assembly. Moreover, as presented above, thedistal or first anchor component can be advanced and deployed through aneedle assembly and at least one component of the proximal or secondanchor component is advanced and deployed from the needle or from ahousing portion of the anchor deployment device. Further, either asingle anchor assembly or multiple anchor assemblies can be deliveredand deployed at an intervention site by the deployment device.Additionally, a single anchor assembly component can for example, beplaced on one side of a prostate or urethra while multiple anchorassembly components can be positioned along an opposite or displacedposition of such anatomy. The number and locations of the anchorassemblies can thus be equal and/or symmetrical, different in number andasymmetrical, or simply asymmetrically placed. In the context ofprostate treatment, the present invention is used for the displacement,compression, and/or retraction of the prostate gland and the opening ofthe prostatic urethra, the delivering of an implant at theinterventional site, and applying tension between ends of the implant.Moreover, drug delivery is both contemplated and described as a furtherremedy in BPH and over active bladder treatment as well as treatingprostate cancer and prostatitis.

Once implanted, the anchor assembly of the present inventionaccomplishes desired tissue manipulation, approximation, compression orretraction as well as cooperates with the target anatomy to provide anatraumatic support structure. In one preferred embodiment, the shape andcontour of the anchor assembly is configured so that the assemblyinvaginates within target tissue, such as within folds formed in theurethra by the opening of the urethra lumen by the anchor assembly. Indesired placement, wispy or pillowy tissue in the area collapses aroundthe anchor structure. Eventually, the natural tissue can grow over theanchor assembly and new cell growth occurs over time. Such cooperationwith target tissue facilitates healing and avoids unwanted side effectssuch as calcification or infection at the interventional site.

Subsequent to the interventional procedure, the patient can be directedto take appropriate drugs or therapeutic agents, such as alpha blockersand anti-inflammatory medicines.

Furthermore, in addition to an intention to cooperate with naturaltissue anatomy, the present invention also contemplates approaches toaccelerate healing or induce scarring. Manners in which healing can bepromoted can include employing abrasive materials, textured connectors,biologics and drugs.

Additionally, it is contemplated that the components of the anchorassembly or selected portions thereof (of any of the anchor assembliesdescribed or contemplated), can be coated or embedded with therapeuticor diagnostic substances (e.g. drugs or therapeutic agents). Again, inthe context of treating a prostate gland, the anchor assembly can becoated or imbedded with substances such as 5-alpha-reductase which causethe prostate to decrease in size. Other substances contemplated includebut are not limited to phytochemicals generally, alpha-1a-adrenergicreceptor blocking agents, smooth muscle relaxants, and agents thatinhibit the conversion of testosterone to dihydrotestosterone. In oneparticular approach, the connector can for example, be coated with apolymer matrix or gel coating that retains the therapeutic or diagnosticsubstance and facilitates accomplishing the timed release thereof.Additionally, it is contemplated that bacteriostatic coatings as well asanalgesics and antibiotics for prostatitis and other chemical coatingsfor cancer treatment, can be applied to various portions of the anchorassemblies described herein. Such coatings can have various thicknessesor a specific thickness such that it along with the connector itselfmatches the profile of a cylindrical portion of an anchor member affixedto the connector. Moreover, the co-delivery of a therapeutic ordiagnostic gel or other substances through the implant deployment deviceor another medical device (i.e. catheter), and moreover an anchorassembly including the same, is within the scope of the presentinvention as is radio-loading devices (such as a capsular or distal endsof implants for cancer or other treatment modalities). In one suchapproach, the deployment device includes a reservoir holding the gelsubstance and through which an anchor device can be advance to pick up adesired quantity of therapeutic or diagnostic gel substance.

It is further contemplated that in certain embodiments, the anchordelivery device can include the ability to detect forces being appliedthereby or other environmental conditions. Various sections of thedevice can include such devices and in one contemplated approach sensorscan be placed along the needle assembly. In this way, an operator candetect for example, whether the needle has breached the targetanatomical structure at the interventional site and the extent to whichsuch breaching has occurred. Other sensors that can detect particularenvironmental features can also be employed such as blood or otherchemical or constituent sensors. Moreover, one or more pressure sensorsor sensors providing feedback on the state of deployment of the anchorassembly during delivery or after implantation are contemplated. Forexample, tension or depth feedback can be monitored by these sensors.Further, such sensors can be incorporated into the anchor assemblyitself, other structure of the deployment device or in the anatomy.

Moreover, it is to be recognized that the foregoing procedure isreversible. In one approach, the connection of an anchor assembly can besevered and a proximal (or second) anchor component removed from thepatient's body. For example, the physician can cut the connector andsimultaneously remove the second anchor previously implanted forexample, in the patient's urethra using electrosurgical, surgical orlaser surgical devices used in performing transurethral prostateresection.

An aspect that the various embodiments of the present invention provideis the ability to deliver an anchor assembly having a customizablelength, each anchor assembly being implanted at a different locationwithout having to remove the device from the patient. Other aspects ofthe various embodiments of the present invention are load-baseddelivery, of an anchor assembly, anchor assembly delivery with a devicehaving integrated connector, (e.g. suture), cutting, and anchor assemblydelivery with an endoscope in the device. The delivery device isuniquely configured to hold the suture with tension during delivery tohelp ensure that the first anchor component sits firmly against a tissueplane (e.g., the outer capsule of the prostate) and is held relativelyfirm as the second anchor component is attached to the connector and thedelivery device. In this aspect, the needle assembly acting as apenetrating member is cooperatively connected to a mechanism that pullson the anchor while the needle assembly is retracted.

It is to be recognized that various materials are within the scope ofthe present invention for manufacturing the disclosed devices. Moreover,one or more components such as distal anchor, proximal anchor, andconnector, of the one or more anchor devices disclosed herein can becompletely or partially biodegradable or biofragmentable.

Further, as stated, the devices and methods disclosed herein can be usedto treat a variety of pathologies in a variety of lumens or organscomprising a cavity or a wall. Examples of such lumens or organsinclude, but are not limited to urethra, bowel, stomach, esophagus,trachea, bronchii, bronchial passageways, veins (e.g. for treatingvaricose veins or valvular insufficiency), arteries, lymphatic vessels,ureters, bladder, cardiac atria or ventricles, uterus, fallopian tubes,etc.

Finally, it is to be appreciated that the invention has been describedhereabove with reference to certain examples or embodiments of theinvention but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unpatentable or unsuitablefor its intended use. Also, for example, where the steps of a method aredescribed or listed in a particular order, the order of such steps maybe changed unless to do so would render the method unpatentable orunsuitable for its intended use. All reasonable additions, deletions,modifications and alterations are to be considered equivalents of thedescribed examples and embodiments and are to be included within thescope of the following claims.

Thus, it will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe invention.

1. A system for deploying an anchor assembly, comprising: a cartridgecarrying the anchor assembly, a handle configured to couple with thecartridge, wherein the cartridge and handle couple by first pivoting thecartridge with respect to the handle and then mating a first alignmentmember on the cartridge with a second alignment member on the handle. 2.The system of claim 1 wherein the first alignment member has awedge-shaped cross section.
 3. The system of claim 1 wherein the secondalignment member has a wedge-shaped cross section.
 4. The system ofclaim 2 wherein the second alignment member comprises a wedge-shapedrecess.
 5. The system of claim 3 wherein the first alignment membercomprises a wedge-shaped recess.
 6. The system of claim 1 furthercomprising a sheath, wherein the first alignment member on the cartridgeand the second alignment recess on the handle are configured to fitwithin the sheath.
 7. The system of claim 1 wherein the cartridgefurther comprises an elongate shaft, the elongate shaft having a biaseddistal portion.
 8. The system of claim 1 wherein the cartridge comprisesreceiving portion and the handle comprises a guide portion.
 9. Thesystem of claim 5 wherein the receiving portion and the guide portionare placed in contact and maintain such contact during the pivoting ofthe cartridge.
 10. The system of claim 1 further comprising a matingmember on the cartridge and a guide member on the handle, wherein themating member and the guide member interact to form the pivot point forthe pivoting of the cartridge.
 11. The system of claim 1 furthercomprising a grip offset from a surface of the cartridge.
 12. The systemof claim 1 further comprising a raised area on the handle sized andconfigured to provide an ergonomic interface for a users' hands.
 13. Asystem for deploying an anchor assembly, comprising: a handle comprisinga cartridge receiving bay having a back end, wherein the back endcomprises an interior guide; a cartridge carrying the anchor assembly,the cartridge comprising a pivoting surface, wherein the pivotingsurface pivots about the interior guide; a handle alignment featurelocated in a region of the handle across the cartridge receiving bayfrom the interior guide; and a cartridge alignment feature located onthe cartridge.
 14. The system of claim 13 wherein the cartridge andhandle are configured to couple by first pivoting the cartridge withrespect to the handle and then mating the handle alignment feature withthe cartridge alignment feature.
 15. The system of claim 13 wherein thehandle alignment feature has a wedge-shaped cross section.
 16. Thesystem of claim 13 wherein the cartridge alignment feature has awedge-shaped cross section.
 17. The system of claim 13 wherein thehandle alignment feature comprises a wedge-shaped recess.
 18. The systemof claim 13 wherein the cartridge alignment feature comprises awedge-shaped recess.
 19. The system of claim 13 further comprising asheath, wherein the cartridge alignment feature and the handle alignmentfeature are configured to fit within the sheath.